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Completed

NCT Number: NCT01192477

Ozone Cardiovascular Effects in Genetically Susceptible People

Increases in air pollution are associated with increases in deaths from cardiovascular disease, but the investigators know little about how ozone air pollution affects the cardiovascular system. The investigators proposed study will determine the effects of ozone on blood vessel and heart function that could worsen illness in people with underlying heart disease. This will be accomplished by studying healthy volunteers who inhale ozone in a controlled clinical study, and also by studying their exposure to ozone and other pollutants during their normal daily activities. The investigators will study volunteers who may be at increased risk for the effects of ozone because of genetic susceptibility. Understanding the effects of ozone on the heart and circulation can help establish appropriate air pollution standards, and provide strategies to protect the most susceptible people.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy,
  • Never-smokers with normal spirometry based on the standards published by Morris and co-workers (Morris et al. 1971), and
  • A normal electrocardiogram. -

Exclusion criteria

  • Any history of habitual smoking.
  • Marijuana smoking within the past 5 years.
  • Pregnancy.
  • Any history of significant organ impairment, chronic respiratory disease, ischemic heart disease, active psychiatric disorder or current drug or alcohol abuse.
  • Occupation involving regular, heavy dust or particle exposure, such as welding, mining, foundry work.
  • FEV1 < 75% of predicted at baseline screening.
  • Subjects with atopy or allergic rhinitis will not be excluded as long as they do not require regular treatment with antihistamines or systemic steroids.
  • Subjects on certain prescription medications such as prednisone or statins will be excluded. Use of other medications will be considered on an individual basis. Subjects will not be asked to discontinue prescription medications for the purposes of this study.
  • Hypertension (blood pressure higher than 140/90 mmHg or on antihypertensive medication).
  • Subject lives outside the Rochester metropolitan area.

Treatment and study plan

Ozone

Other

All subjects will have a 3-hour exposure to clean air, a 3-hour exposure to clean air with lower ozone (0.1 ppm), and a 3-hour exposure to clean air with higher ozone (0.2 ppm). Exposures will take place at least 3 weeks apart. Order of exposure will be randomized for each subject.

Other names: Ozone exposure, Ozone air pollution

Primary outcomes

  1. Nitric oxide bioavailability

    Time frame: Before and 3 hours after ozone exposure

    We hypothesize that systemic vascular effects of exposure to ozone will be reflected in reductions in arterial blood nitrite or its A/V gradient. This will require simultaneous collection of venous and arterial blood.

Secondary outcomes

  1. Evidence of endothelial injury

    Time frame: Before and 3 hours after ozone exposure

    We hypothesize that systemic vascular effects of exposure to ozone will alter markers of vascular function and inflammation. Flow cytometry will be used to detect activated platelets and pro-coagulant circulating microparticles.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Conservation of Clean Air and Water in Europe (CONCAWE)
  • Exxon Mobil
  • National Institute of Environmental Health Sciences (NIEHS)

Registry information

Acronym: OZCARD

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 1, 2010
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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